Manager, Biostatistics

US-Remote

Full time

R01559

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

The Manager, Biostatistics (Oncology) provides statistical leadership and support for oncology clinical development programs from protocol development through clinical study reporting and regulatory submission. The individual serves as the lead statistician for one or more clinical studies and collaborates with cross-functional teams including Clinical Development, Statistical Programming, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and external partners to ensure the successful execution of clinical trials.

• Serve as lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoint selection, sample size determination, randomization methodology, and analysis strategy.
• Contribute to the development and review of clinical study protocols.
• Author and review Statistical Analysis Plans (SAPs).
• Collaborate with Statistical Programming in the development and review of analysis datasets, tables, listings, and figures (TLFs).
• Review statistical outputs and ensure the quality, consistency, and accuracy of study deliverables.
• Interpret study results and communicate findings to multidisciplinary project teams.
• Contribute to the preparation of Clinical Study Reports (CSRs), abstracts, publications, and regulatory documents.
• Support regulatory submissions and responses to health authorities.
• Collaborate with CRO statisticians and programming teams to ensure timely and high-quality deliverables.
• Ensure compliance with regulatory requirements, company procedures, and industry standards.
• Participate in departmental initiatives to improve statistical processes and standards.
• Provide technical guidance and mentoring to junior statisticians as needed.

• MS and 4 yrs of experience within in Statistics, Biostatistics, or a related quantitative discipline or PhD in Statistics, Biostatistics, or a related quantitative discipline.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH, and other applicable regulatory guidelines.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Experience supporting the design, analysis, and reporting of clinical trials.
• Proficiency in SAS programming; experience with R is desirable.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Experience contributing to protocols, SAPs, CSRs, and regulatory submission documents.
• Oncology clinical development experience is preferred.
• Experience working with CROs and external vendors is desirable.

• Scientific rigor and strong attention to detail.
• Effective written and verbal communication skills.
• Ability to communicate statistical concepts to both technical and non-technical audiences.
• Strong organizational and project management skills.
• Ability to manage multiple priorities in a fast-paced development environment.
• Commitment to quality, innovation, and continuous improvement.

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$ - $

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid…